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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Model Number 02.124.412
Device Problem Break (1069)
Patient Problems Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional procodes: hrs, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A device history record review has been requested.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on (b)(6) 2019, the patient underwent hardware removal due to non-union and a broken variable angle locking compression (va-lcp) curved condylar distal femur plate.Ten (10) variable angle locking screws and three (3) cortex screws were also removed.The patient was originally treated with an open reduction and internal fixation (orif) surgery of a distal femur on an unknown date.The procedure was successfully completed with no surgical delay.Patient status was fine and good.Concomitant devices: va locking screws (part: unknown, lot: unknown, quantity: 10), 4.5 cortex screws (part: unknown, lot: unknown, quantity: 3).This report is for a 4.5mm va-lcp curved condylar plate.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional patient information: patient's height reported as 5 feet 1 inches a device history record (dhr) review was conducted: part: 02.124.412s, lot# l773527, manufacturing location: mezzovico, released to warehouse date: 06march2018, no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Concomitant devices: 5.0mm variable angle locking screw (part: 02.221.2xx , lot: unknown, quantity: 10), 4.5mm cortex screws (part: 214.8xx , lot: unknown, quantity: 3).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.Corrected data: expiration date.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Brand name, part number, provided for reporting.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/RT-STER
Type of Device
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8325209
MDR Text Key135695020
Report Number2939274-2019-56383
Device Sequence Number1
Product Code JDP
UDI-Device Identifier10886982042859
UDI-Public(01)10886982042859
Combination Product (y/n)N
PMA/PMN Number
K110354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number02.124.412
Device Catalogue Number02.124.412S
Device Lot NumberL773527
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight98
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